Explore the medical device requirements currently available for New Zealand, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
No manufacturer or sponsor may publish any statement that directly or by implication indicates or suggests that inclusion of a device in the WAND database is an endorsement of its safety or suitability for use by the Director-General or the Ministry of Health.
Advertising of devices with claimed therapeutic properties must comply with the Medicines Act and Regulations: Medicines Act 1981 Part 4 (ss 56-62) restricts false or misleading advertising, requires identification of the advertiser, and restricts claims for Schedule 1 disease/condition classes; 'publish' expressly covers advertising via the internet; Medicines Regulations 1984 regs 7, 10 and 11 add device advertising rules (including no claiming official approval).
What expires, what is retained periodically, and when must renewal start?
WAND entries carry no expiry date: the Medicines (Database of Medical Devices) Regulations 2003 (regs 1-15) contain no renewal, re-notification or retention event; the only continuing duty is to correct information within 10 working days under reg 8, and Medsafe confirms there are no on-going fees.
Absence claim is scoped to this instrument, read in full; fee statement at res-nz-wand-page.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
If recorded WAND information ceases to be accurate or complete — whether through a change of circumstances (for example a change in the name of the manufacturer or sponsor), a lapse in any certification relating to the device, or otherwise — the sponsor must notify the correct details within 10 working days.
What local class follows from which rules and decisive product facts?
Schedule 2 rule outcomes: mammary implants Class III (rule 22); devices incorporating a medicine Class III (rule 14); contraception devices Class IIb, implantable/long-term invasive contraception Class III (rule 15); blood bags Class IIb (rule 19); reusable surgical instruments for transient use Class I (rule 7(4)); active implantable devices Class AIMD with controllers/monitors of AIMDs Class III (rule 20); export-only devices Class I (rule 21); contact-lens disinfectants Class IIb (rule 16).
Classes I, IIa, IIb, III and AIMD (Medicines (Database of Medical Devices) Regulations 2003).
i
Class I
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
aimd
Class AIMD
highest
Medsafe
Classification principles (reg 13): software that drives or influences a device has the same risk classification as the device; accessories are classified separately from the device; devices used in combination are each classified separately; classification follows the intended purpose and, where several rules apply, the highest classification prevails.
The sponsor determines the device's risk classification and, when notifying, declares that the product is a medical device and is correctly classified; Medsafe does not classify devices and states it is not able to make a classification determination.
Medsafe guidance (res-nz-classification): 'Medsafe is not able to make a determination as to the risk classification of a medical device'.
Which clinical or IVD performance evidence or study is required and accepted?
Medsafe does not regulate or approve clinical trials for medical devices in New Zealand, but requests that it be informed of them before commencement; trials require ethics committee approval, ISO 14155:2011 good clinical practice is expected, and trial devices are exempt from WAND notification under Schedule 1(h). Serious unexpected adverse events during trials should be reported under Medsafe's voluntary adverse event reporting scheme.
Is the product a device, IVD, accessory, software, or borderline product locally?
IVDs are categorised as medical devices under the Medicines Act 1981, but are currently exempt from mandatory notification to the WAND database; they may be voluntarily notified, and suppliers are expected to notify Medsafe of safety issues or corrective actions.
Effective from 2004-01-01
Reverse of the baseline hint (general devices mandatory, IVDs exempt); exemption basis is the Gazette declaration under Schedule 1(i).
A medical device is any device, instrument, apparatus, appliance or other article intended to be used in, on, or for human beings for a therapeutic purpose, that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means (though it may be assisted in its function by such means) — Medicines Act 1981 s 3A; the Database Regulations apply the same meaning.
s 3A text also quoted on Medsafe's definitions page (res-nz-definitions); definition amended 1 July 2014 by Medicines Amendment Act 2013 s 50.
Therapeutic purpose (Medicines Act 1981 s 4) includes preventing, diagnosing, monitoring, alleviating, treating or curing any disease or ailment, investigating or modifying physiological processes, testing susceptibility to disease, contraception, and pregnancy testing; claiming a therapeutic purpose for a product defines it as a therapeutic product subject to the Act.
Which evidence, local deltas, formats, and signatures are required?
With each notification the sponsor (or an employee) must provide a declaration that: the product is a medical device and is correctly classified under the regulations; the sponsor will only recommend the device for its intended purpose; and the information supplied is accurate and complete.
Self-declaration replaces any regulator assessment or certification.
Information required per non-exempt device (reg 5): the risk classification; names of manufacturer and sponsor with their registered-office/principal-place addresses and a contact phone or email; and the product description attributed by the Global Medical Device Nomenclature System (GMDNS). For Class III and Class AIMD devices a unique product identifier (trade or brand name, combined if required with a form of product identification) must also be entered. Same-kind Class I/IIa/IIb devices from one manufacturer with the same GMDNS code and class may be notified as a single entry.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
'Sponsor' means a person in New Zealand who exports or arranges export of the device from New Zealand, imports or arranges import of the device into New Zealand, or manufactures or arranges manufacture of the device in New Zealand for supply; it excludes a person acting on behalf of another person who is resident in, or carrying on business in, New Zealand. The sponsor holds the WAND duties under regs 5-10.
The sponsor must be recorded in the database with the address of its registered office or principal place of business in New Zealand, plus a contact telephone number or email address for both sponsor and (overseas or local) manufacturer.
Functions as the local-contact requirement in lieu of an authorised-representative regime.
Which establishment licences, importer permissions, and distribution controls apply?
New Zealand operates no establishment licence or importer authorisation scheme for medical devices: the import control is that a person in New Zealand who imports or arranges importation qualifies as the 'sponsor' and must comply with the WAND notification, declaration and update duties under the Database Regulations.
Grounded on the 'no approval system' statement plus the sponsor/notification structure of regs 3-10; no licence instrument exists in the opened instruments.
What regulator fee applies to this class, route, event, and date?
WAND notification is free of charge: there is no notification fee and there are no on-going fees for maintaining a device in the database.
Explanation page adds: 'There are no charges associated with the database.' (res-nz-wand-explanation).
Which label and IFU elements, languages, symbols, and translation controls apply?
Medicines Regulations 1984 reg 12(4): no person may sell a medical device that does not bear the name of the manufacturer, or the name of the manufacturer's distributor in New Zealand.
This is the main binding labelling rule for devices alongside advertising controls.
There are no specific legislative or regulatory requirements for medical device IFUs under the Medicines Act 1981 or Medicines Regulations 1984; Medsafe recommends following international best practice (GHTF/SG1/N43:2005) when preparing IFUs. Electronic IFU may be supplied in New Zealand if the sponsor can provide a hardcopy on user request.
No language requirements for IFU/labels are stated on the page.
Which current law, regulation, guidance, and transition provisions apply?
Depending on the device, other statutes also apply: Electricity Act 1992 (all electrically powered devices; Energy Safety), Radiation Protection Act 1965 (Office of Radiation Safety), Radiocommunications Act 1989 (Radio Spectrum Management), HSNO Act 1996 (EPA), Contraception, Sterilisation and Abortion Act 1977 (condoms), Human Tissue Act 2008, Health (Needles and Syringes) Regulations 1998, and PECPR Regulations 1999 (autoclaves/pressure vessels). It is the supplier's responsibility to ensure compliance with all applicable legislation.
Medicines Act 1981
WAND (Web Assisted Notification of Devices), operated for the Director-General of Health
Medsafe
Effective from 2004-01-01
Corrected: names the exact instruments (SR 2003/325, reg 2 commencement 1 January 2004 per res-nz-dbregs) instead of a generic surface; IVD notification exemption recorded under device-definition and registration facts.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
The sponsor must put in place any procedures necessary to ensure compliance with the notification, information and update regulations (regs 5, 6 and 8). Medsafe additionally expects every sponsor to hold a written recall procedure describing how a recall action will be initiated, and to report progress and final closure of recall actions.
Written recall procedure expectation from res-nz-recalls.
Which current form, portal, account, and submission package must be used?
WAND (Web Assisted Notification of Devices) online database
devices@health.govt.nz
Medsafe adverse event report forms published separately for industry (sponsors), health professionals, and consumers
Adverse event forms at res-nz-adverse-events; notification data elements set by reg 5 (res-nz-dbregs).
Which QMS, audit, inspection, and certificate scope is accepted or required?
Medical devices are within the reach of New Zealand's statutory inspection machinery. Part 5 of the Medicines Act 1981 (Enforcement) gives an officer, at any reasonable time, power to enter and inspect premises or vehicles where an 'article to which this section applies' is manufactured, packed, stored or kept for sale, to examine any process of manufacture or packing and the means employed for testing materials, and to examine and copy the records relating to that manufacture, packing, storage or keeping for sale. Section 63(1) defines that expression to include any medical device, and also any equipment used or intended to be used in connection with the manufacture, packing or labelling of a medicine, medical device or cosmetic, and any package, container, advertising material or labelling material used in that connection.
An officer appointed under the Medicines Act 1981 (and any person assisting under the officer's direct supervision)
Medicines Act 1981 (1981 No 118)
medical devices, medicines, cosmetics, and the equipment, packaging and labelling material used with them
Retrieved from the New Zealand Legislation website (legislation.govt.nz), the official source of New Zealand legislation, as rendered HTML via the browserless transport on 2026-09-16. Verbatim: '63 Powers of officers (1) In this section the expression article to which this section applies means— (a) any medicine; and (b) any medical device; and (c) any cosmetic; and (d) any equipment used or intended to be used in connection with the manufacture, packing, or labelling of anything referred to in any of paragraphs (a) to (c); and (e) any package or container, and any advertising material or labelling material, used or intended to be used in any such connection. (2) An officer, and any other person assisting him and acting under his direct supervision, may at any reasonable time— (a) enter and inspect any premises (not being a dwellinghouse) or vehicle (including any fixtures, fittings, or appliances in the premises or vehicle) where the officer reasonably believes that any article to which this section applies is manufactured, packed, stored, or kept for sale:' and '(e) examine any process of manufacture or packing of any article to which this section applies, and the means employed at any stage in the processes of manufacture or packing for testing the materials after they have been subjected to those processes:'.
Which recall, FSCA, notice, and authority-coordination duties apply?
Recalls and other corrective actions should be conducted in consultation with Medsafe according to the New Zealand Medicines and Medical Devices Recall Code (latest edition in effect from 1 December 2015). Sponsors should discuss the issue with Medsafe before initiating any recall or non-recall action, provide progress reports, and submit a final closure report; Medsafe should also be advised of post-market actions for safety reasons on exempt devices.
Effective from 2015-12-01
No numeric regulatory deadlines for recall execution appear on the page.
Which registration, notification, listing, reliance, or conformity route applies?
Exempt from WAND notification (Schedule 1): devices that are also medicines; custom devices made to a registered health professional's design specification for a particular patient; devices supplied to a practitioner for a particular patient; devices held by NZ Customs pending export; IVDs used only within one laboratory; lab-made tests supplied to another laboratory; personal-use imports; devices imported for clinical trials; and classes declared exempt by Director-General Gazette notice.
Medsafe guidance version at res-nz-exempt.
The Director-General declared, under paragraph (i) of Schedule 1 and by notice in the New Zealand Gazette, that 'any diagnostic device that is commonly known as an in vitro diagnostic device' is an exempt class of medical device, effective 1 January 2004 — removing the mandatory WAND notification duty for IVDs.
Effective from 2004-01-01
For medical devices to be legally supplied in New Zealand they must be notified to the WAND database; notification is a mandatory requirement for importers, exporters and local manufacturers (sponsors) of non-exempt devices.
Medsafe explanation page: 'It is a mandatory requirement for importers, exporters and local manufacturers to notify their medical devices to the database.'
notification
No
No premarket approval or assessment system exists for medical devices under the Medicines Act 1981. Sponsors of non-exempt devices must notify device information to the free WAND database within 30 working days of becoming sponsor. IVDs are exempt (voluntary notification only). Notification does not mean or imply the device has been assessed by Medsafe.
Confirmed with a precise locator; 30-working-day duty is reg 6 (res-nz-dbregs).
A sponsor who contravenes reg 6 (notification), reg 8 (updates), reg 9 (compliance procedures) or reg 10 (prohibited statements) commits an offence punishable on conviction by a fine not exceeding $500.
Fine level amended 1 July 2013 (Criminal Procedure Act 2011 s 413).
Which foreign decisions or evidence can be reused, with what effect and conditions?
Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.
Prior approval / evidence record
At renewal, Bahrain requires a Free Sale Certificate (FSC) or Certificate to Foreign Government issued by the regulatory authority of the country of origin or of a reference country (Registration Guideline 9.1, section 10 item 4). The guideline's glossary (item 14) defines reference countries as Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland and Belgium, so a certificate from one of those authorities substitutes for an origin-country free-sale certificate. A Free Sale Certificate is also required on manufacturer acquisition (section 12).
Free Sale Certificate or Certificate to Foreign Government from the country of origin or from a reference country (Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium)
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Verbatim source passages: "Free Sale Certificate (FSC) or Certificate to foreign government issued by the regulatory authority of the country of origin or a reference country." and "Reference countries: Saudi Arabia, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium."
Prior approval / evidence record
To obtain an NHRA classification letter, the applicant must supply a Free Sale Certificate or Registration Certificate issued by the competent authority of the country of origin or by one of the reference countries listed in the classification guideline (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland, Belgium), together with a recognised quality assurance certificate such as ISO 13485, CE mark or FDA.
Registration certificate or Free Sale Certificate from SFDA (Saudi Arabia), US FDA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, New Zealand, France, Holland or Belgium
Origin Country Evidence
Evidence Only
classification
Yes
Yes
Verbatim source passage: "1. Free Sale Certificate OR Registration Certificate issued from competent authority in country of origin classifies the product as a medical device. 2. Free Sale Certificate OR Registration Certificate issued from one of the following reference countries: (SFDA, USA, UK, Australia, Canada, Japan, Switzerland, Ireland, Denmark, Newzland, France, and Holland, Belgium.)."
Regulatory reference
EDA recognizes reference countries: EU member states plus Australia, Canada, Iceland, Ireland, Japan, New Zealand, Norway, Switzerland, United Kingdom and United States of America; devices from these countries get reduced documentation, while devices from non-reference countries need extra evidence.
Variation guideline v03 (res-eg-variations) lists the same set plus Croatia and Liechtenstein.
Regulatory reference
A device registered, or approved for marketing and actually marketed, in a 'recognized state' (מדינה מוכרת) is registered in the Israeli register for a period not exceeding the period it may be marketed in that state, capped at 5 years from Israeli registration. Recognized states are listed in the First Addendum to the law — 21 states including the US, UK, Germany, France, Italy, Spain, the Netherlands, Belgium, Ireland, Denmark, Sweden, Finland, Norway, Iceland, Greece, Portugal, Austria, Switzerland, Australia, Canada and New Zealand (no single 'EU' entry: member states are listed individually).
First Addendum list per the official Sefer HaChukim text of the law held from gov.il.
Prior approval / evidence record
For IVDs, DINAVISA decides within 30 business days for products manufactured nationally or in a country of Annex I, within 45 business days for products manufactured outside Annex I but registered and commercialised in an Annex I country (which must additionally file the foreign registration certificate and free-sale certificate), and within 120 business days for other imports. Annex I names high-surveillance and adequate-surveillance authorities and the full MERCOSUR members; the United States and Japan are on it and Korea is not.
Sanitary registration and free-sale certificate in force in an Annex I country — high-surveillance authorities (Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden, Switzerland) or adequate-surveillance authorities (Australia, Chile, Cuba, Finland, Hungary, Ireland, Luxembourg, Mexico, Norway, New Zealand); Annex I also lists full MERCOSUR members (Argentina, Brazil, Paraguay, Uruguay) and PAHO/WHO reference authorities
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Source language: Spanish. Translation of the quoted Annex I heading and entries: 'Countries with High and Adequate Sanitary Surveillance Authorities (Law 3283/07 Article 11)' / 'Countries with high sanitary surveillance regulatory authorities: Germany, Austria, Belgium, Canada, Denmark, Spain, United States, France, Israel, Italy, Japan, Netherlands, United Kingdom, Sweden and Switzerland.' / 'Full MERCOSUR members: Argentina, Brazil, Paraguay and Uruguay.' The excerpt is taken from the resolution's own Annex I; Art. 6 supplies the 30- and 45-business-day clocks.
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Same position as a CE certificate: useful evidence for the sponsor, irrelevant to the notification itself.
None — there is no review period to shorten
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
No foreign regulatory approval is required or assessed: there is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand, and WAND notification does not mean or imply that a device has been assessed by Medsafe (quality, safety, efficacy, or performance).
Confirms the baseline reliance edge: notification_without_premarket_approval, local WAND application required, no target decision retained.
Regulatory reference
New Zealand has no pre-market approval system for medical devices: there is no mandatory requirement for a device to be approved by any regulator before supply, and WAND notification does not imply any Medsafe assessment. A China NMPA certificate therefore has no regulatory role; the sponsor simply notifies the device to WAND and meets Medicines Act, labelling, advertising and post-market obligations.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
new-zealand
All classes
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2004-01-01
Source passage: There is no approval system for medical devices under the Medicines Act 1981. There is no mandatory requirement for medical devices to be approved by any medical device regulator prior to being supplied in New Zealand. Notification to the WAND database does not mean or imply that a medical device has been assessed by Medsafe in terms of quality, safety, efficacy, or performance.
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Neither required nor rewarded. WAND is a sponsor notification rather than an assessment: Medsafe does not review the device before it goes on the database, so there is no decision for a foreign approval to influence. The certificate matters as evidence the sponsor holds behind the notification.
None — there is no review period to shorten
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
Custom devices — manufactured in response to a registered health professional's request specifying the design characteristics and intended for use only in relation to a particular patient (Schedule 1(b)) — and devices supplied to a practitioner for use in relation to a particular patient (Schedule 1(c)) are exempt from WAND notification.
A medical device imported by a person solely for that person's own use is an exempt medical device (Schedule 1(g)) and need not be notified to WAND; all other Medicines Act requirements still apply.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Because WAND is a notification-only system with no application decision, deficiency responses and appeal rights for market entry do not arise; Medsafe states notification does not mean or imply a device has been assessed for quality, safety, efficacy or performance. WAND access and submission problems are handled through devices@health.govt.nz.
Which UDI, device listing, database, and traceability duties apply?
The 2003 Database Regulations establish no UDI scheme; device traceability rests on the WAND entry — GMDNS product description for all notified devices plus a unique product identifier (trade/brand name) for Class III and Class AIMD devices. Medsafe uses the WAND database to identify all sponsors of a device when a safety issue arises.
Post-market identification use per res-nz-wand-explanation.
What is reportable, by whom, where, in what format, and by what deadline?
For events involving death or serious deterioration in health, sponsors should submit an initial report as soon as possible and within 10 calendar days, and a final report within 120 calendar days; minor injury and product quality events require a final report within 120 calendar days (initial reports of minor injury events are no longer required).
Anyone can report an issue associated with a medical device to Medsafe at devices@health.govt.nz; patients, caregivers, healthcare professionals and suppliers are encouraged to report under the voluntary scheme. Non-reportable events include: deficiencies found before use, patient-condition root causes, service/shelf-life issues, correct fail-safe (malfunction protection) operation, events already described in a recall/alert, improper use or maintenance, and expected foreseeable events fully described in the IFU.
Medsafe no longer requires initial reports of minor injury events, only final reports.
new-zealand:medical-device
new-zealand
Classes I, IIa, IIb, III and AIMD (Medicines (Database of Medical Devices) Regulations 2003).
i
Class I
low
iia
Class IIa
medium
iib
Class IIb
high
iii
Class III
highest
aimd
Class AIMD
highest
Medsafe
official-source-verified
Medicines (Database of Medical Devices) Regulations 2003, regs 11-13 and Schedule 2
https://www.legislation.govt.nz/regulation/public/2003/0325/latest/whole.html
2026-08-25
New Zealand
new-zealand
NZ
🇳🇿
Medsafe (Ministry of Health)
Medsafe
asia-pacific
3
4-class (I, IIa, IIb, III) — WAND notification-based system
wand-notification
All devices (WAND notification)
low
Notification to the Web Assisted Notification of Devices (WAND) database
0
0
days
1
2
months
No
No
Yes
official-verified
Medsafe — Regulatory Requirements for Sponsors: reg 6 requires notification within 30 working days of becoming the sponsor (read as running from the date the device first arrives in New Zealand), reg 8 requires corrections within 10 working days, reg 10 forbids treating notification as endorsement, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence fined up to $500
https://www.medsafe.govt.nz/regulatory/devicesnew/3-6RegulatoryRequirements.asp
2026-08-30
CE Mark (EU MDR)
Yes
Neither required nor rewarded. WAND is a sponsor notification rather than an assessment: Medsafe does not review the device before it goes on the database, so there is no decision for a foreign approval to influence. The certificate matters as evidence the sponsor holds behind the notification.
None — there is no review period to shorten
FDA 510(k)/PMA
Yes
Same position as a CE certificate: useful evidence for the sponsor, irrelevant to the notification itself.
None — there is no review period to shorten
Yes
New Zealand Sponsor
No
Not accepted
Notification does not expire, but reg 8 requires corrections within 10 working days of any notified detail ceasing to be correct
2026-08-30
official-verified
2026-08-30
Medicines (Database of Medical Devices) Regulations 2003 — WAND notification duties
https://www.legislation.govt.nz/regulation/public/2003/0325/latest/whole.html
2003-12-15
2026-08-30
Medsafe — Regulatory Requirements for Sponsors: reg 6 requires notification within 30 working days of becoming the sponsor (read as running from the date the device first arrives in New Zealand), reg 8 requires corrections within 10 working days, reg 10 forbids treating notification as endorsement, and reg 14 makes contravention of regs 6, 8, 9 or 10 an offence fined up to $500
https://www.medsafe.govt.nz/regulatory/devicesnew/3-6RegulatoryRequirements.asp
2026-08-30
Therapeutic Products Act Repeal Act 2024 (2024 No 55) — repealed the Therapeutic Products Act 2023 on 18 December 2024 before its 1 September 2026 commencement, leaving devices under the Medicines Act 1981 and the WAND regulations
https://www.legislation.govt.nz/act/public/2023/0037/latest/whole.html
2024-12-18
2026-08-30
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
Gather technical documentation, quality management system (QMS) records, and clinical data required by Medsafe. Appoint a New Zealand Sponsor.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Medsafe including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Medsafe reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. Medsafe may issue questions.
0 days
⚙️
5
Registration Approval
Upon successful review, Medsafe issues New Zealand market authorization certificate.
1-2 weeks
✅
new-zealand
New Zealand
NZ
Medsafe
0
0
NZD
Yes
0
0
NZD
Yes
wand-notification
WAND database notification (all device classes)
NZD
0
NZD 0
Per notification
Notification is free and there are no on-going fees; Medsafe states "There are no charges associated with the database."
exact-current
official-verified
https://www.medsafe.govt.nz/regulatory/wand.asp
Medsafe WAND database: notification is free with no ongoing fees
2026-08-25
2026-08-25
official-verified
Medsafe WAND database: notification is free with no ongoing fees
https://www.medsafe.govt.nz/regulatory/wand.asp
2026-08-25
2026-08-25
exact-current
Yes
new-zealand
New Zealand
high
electricity-act-compliance
Electricity Act 1992 compliance
General Electrical Components
Mandatory If Feature
Electrically Powered Device
Medsafe other-legislation page still points electrically powered devices at the Electricity Act 1992 and its associated Energy Safety regulations. Schedule 4 of the Electricity (Safety) Regulations 2010 (declared medium/high-risk articles and the Regulation 83 SDoC) was not opened in this pass, so no claim is made that a given medical device is a declared article.
reviewed
radiation-safety-act-source-and-use-licence
Radiation Safety Act 2016 source and use licences
Ionizing Radiation
Mandatory If Feature
Irradiating Apparatus Or Radioactive Material
The Radiation Protection Act 1965 is spent. Radiation Safety Act 2016 s 5 defines irradiating apparatus as electrical equipment that emits ionising radiation and a radiation source as radioactive material or an irradiating apparatus. Section 13 forbids, unless the Act or regulations provide otherwise, manufacturing, possessing, managing or controlling a radiation source without a source licence, using a radiation source without a use licence, and importing or exporting radioactive material without a consent. Section 17 is the source licence; s 15 lists the limited cases where a source licence is not required (including transport). Import of an X-ray generator is therefore a possession/control question under s 13(a), not the s 13(c) radioactive-material consent.
candidate
radiocommunications-act-compliance
Radiocommunications Act 1989 supplier declaration against the Radio Standards Notice
Radio Spectrum
Mandatory If Feature
Radio Device
Radiocommunications Regulations (Radio Standards) Notice 2025 (Gazette 2025-go4751, in force 1 September 2025, revoking the 2023 notice) Table 1 puts Short Range Devices 9 kHz–40 GHz on AS/NZS 4268 at Level of Conformity A1, and Medical Implant Communication Systems in 402–406 MHz on EN 301 839 V2.1.1 at A1. RSM Step 4 requires a Supplier Declaration of Conformity under the Radiocommunications Act 1989 for every A1 product (and for all level 2, 3, A2 and A3 products). Products that complied with the 2023 notice on 1 September 2025 remain compliant under the 2025 notice (transitional provision on the Gazette page).
candidate
pecpr-pressure-vessel-certification
PECPR pressure-vessel certification
General Electrical Components
Mandatory If Feature
Autoclave Or Pressure Vessel
Autoclaves and pressure vessels must comply with the Pressure Equipment, Cranes and Passenger Ropeways (PECPR) Regulations 1999; condoms must meet standards under the Contraception, Sterilisation and Abortion Act 1977; the supplier bears responsibility for identifying all applicable legislation.
unresolved
regulation-62-performance-claims
Regulation 62 physical-force performance claims
Non Ionizing Radiation
Evidence Only No Separate Certificate
Device With Physical Force Claims
Medicines Regulations 1984 reg 62: a medical device claimed to operate by inducing, concentrating, directing or producing magnetic, galvanic, electrical, electromagnetic, radiation or vibratory forces must not be sold unless the claimed properties are quantitatively described to the purchaser in writing in terms measurable by scientific physical means and the device demonstrably has those properties.
reviewed
New Zealand Gazette
Radiocommunications Regulations (Radio Standards) Notice 2025 — SRD AS/NZS 4268 A1 and MICS EN 301 839 A1
https://gazette.govt.nz/notice/id/2025-go4751
Radio Spectrum Management (MBIE)
Supplier Declaration of Conformity required for all A1 radio products
https://www.rsm.govt.nz/business-individuals/supplier-compliance/steps/step-4
New Zealand Legislation
Radiation Safety Act 2016 ss 5, 13, 15 and 17 — source licence, use licence and irradiating apparatus
https://www.legislation.govt.nz/act/public/2016/0006/latest/DLM6339547.html
Medsafe
Other legislation — Electricity Act 1992, Radiocommunications Act 1989, PECPR 1999
https://www.medsafe.govt.nz/regulatory/devicesnew/2Legislation.asp
Medsafe
regulation 62 performance-claim requirements for physical-force devices
https://www.medsafe.govt.nz/regulatory/devicesnew/1Definition.asp
